The U.S. Food and Drug Administration (FDA) has granted approval for the technology transfer of Cinryze drug product manufacturing process to the Shire manufacturing site in Vienna, Austria.
“With the FDA’s approval of the tech transfer, we are pleased to strengthen our supply reliability for adult and adolescent HAE patients who count on Cinryze to help prevent attacks,” said Matt Walker, Head of Technical Operations.
Shire will begin commercial manufacturing of Cinryze drug product in Vienna in the first quarter of 2018. Cinryze will also continue to be produced by a third-party supplier, providing an additional supply source to meet patient demand.
Cinryze is one of the leading therapies approved for the treatment of HAE in adolescent and adult patients. It can help reduce how often attacks occur, how severe they are, and how long they last. Shire’s OnePath program offers patients help with their access to the therapy and product support needs.